- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497896
Playtime Open Globe Injuries in Children
July 22, 2021 updated by: Khaled Abdelazeem, Assiut University
Epidemiology, Aetiologies, and Complications of Playtime Open-globe Injuries in Children
This study investigated the epidemiology, aetiologies, and complications of playtime open-globe injuries in children at the Assiut University Hospital, Egypt, between January to July 2016.
Study Overview
Detailed Description
This prospective study was conducted at the Department of Ophthalmology, Assiut University Hospital, which is the largest tertiary referral hospital in Upper Egypt and provides 24-hour ophthalmic emergency services for six governorates.
The study included all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period.
Demographic information (age and sex), the site and mechanism of injury, the site of ocular laceration (corneal, scleral or corneoscleral) and associated complications were recorded and analysed.
Study Type
Observational
Enrollment (Actual)
81
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
all children (age ≤18 years) admitted to Assiut university hospital with open-globe injuries that occurred during playtime over a 6-month study period (January-July 2016).
Description
Inclusion Criteria:
- all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period (January-July 2016).
Exclusion Criteria:
- Open globe injuries in patients olader than 18 years.
- Closed globe injuries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity (in Decimal using Snellen chart) after repair of open globe injury
Time Frame: 1 day
|
measurement of corrected distant visual acuity after wound repair.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
July 31, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
July 30, 2020
First Posted (Actual)
August 4, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 22, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17300438
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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